Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Quality of Life RAND 36-Item Health Survey
研究概览
简要总结
The purpose of this study is to compare a minimally invasive surgical procedure and medication management in stroke patients with Atrial Fibrillation. The two treatment options are a minimally invasive surgical procedure or the use of medications.
详细描述
Must have had a stroke or transient ischemic attack (TIA) and have Atrial Fibrillation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a history of stroke and paroxysmal, persistent or permanent AF.
- •Ischemic stroke or TIA with documented paroxysmal or persistent atrial fibrillation. A TIA will meet inclusion criteria as a sudden-onset focal neurological symptom or sign lasting at least 10 minutes but less than 24 hours with or without evidence of acute brain ischemia on diffusion weighted MRI imaging.
- •Eligible symptoms INCLUDE hemiplegia or hemiparesis, monoplegia, or language disturbance other than isolated dysarthria.
- •Symptoms that will NOT QUALIFY AS TIA INCLUDE transient monocular blindness in both eyes, dysarthria, vertigo,isolated sensory symptoms, confusion, memory loss, nonspecific complaints of dizziness, or syncope.
排除标准
- •Recent stroke (< 1 month).
- •Age < 18 or > 80 years; Ejection Fraction < 25%• Presence of left atrial appendage thrombus on CT or echocardiography
- •Previous empyema or thoracic surgery, preventing access to the pulmonary veins via thoracoscopy.
- •Left Atrial Diameter > 55mm.
- •Contraindication to anticoagulation with Coumadin.
- •Mitral insufficiency (> 2+)
- •• • Contraindications to MRI
- ••Artificial heart valve prosthesis
- •Aneurysm clips
- •Implanted drug infusion device or pump
- •Any type of neurotranstimulator
- •Any type of bone growth stimulator
- •Cochlear implants or inner ear prosthesis
- •Any intravascular coils, filters, or stents
- •Shrapnel or bullets
- •Other metallic implants or devices specify which
- •Permanently tattooed eyeliner
- •Are you pregnant or suspect to be pregnant?
结局指标
主要结局
Quality of Life RAND 36-Item Health Survey
时间窗: Change in baseline, 3 month, and 6 month
Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The RAND 36-Item Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores which will have a 0 to 100 range.
次要结局
未报告次要终点